Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125255
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2005-07-27
Brief Title:
S-Caine Peel Skin Numbing Cream to Treat Pain During Vascular Access Procedures in Children
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo Controlled Parallel Study Evaluating the Efficacy of S-Caine Peel Lidocaine 7 and Tetracaine 7 Cream for Induction of Local Dermal Anesthesia Before Vascular Access Procedures in Children
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pain associated with medical procedures is often under-treated in children Children often undergo painful procedures with little or no anesthetic even when effective therapy is available Reasons for not providing available therapy in children include concerns over adverse side effects as well as the length of time necessary to provide adequate anesthesia Recent guidelines strongly advocate for the proactive treatment of pain in children including the pain associated with medical procedures
S-Caine Peel lidocaine 7 and tetracaine 7 cream is a eutectic formulation of lidocaine and tetracaine The purpose of this study is to evaluate whether S-Caine Peel is effective in providing topical local dermal anesthesia prior to a vascular access procedure in children 5 through 17 years of age
S-Caine Peel lidocaine 7 and tetracaine 7 cream is a eutectic formulation of lidocaine and tetracaine The purpose of this study is to evaluate whether S-Caine Peel is effective in providing topical local dermal anesthesia prior to a vascular access procedure in children 5 through 17 years of age
Detailed Description:
This was a randomized double-blind placebo-controlled parallel study that evaluated the effectiveness of S-Caine Peel in providing local dermal anesthesia for vascular access procedures in children who were 5 through 17 years of age Patients were randomized 11 to receive either one application of S-Caine Peel or one application of placebo for 30 minutes prior to a vascular access procedure
During the screening visit the study was fully explained to each patients legal guardian and written informed consent was obtained Whenever possible patients provided assent The screening visit also included evaluating eligibility criteria obtaining a medical history including skin type demographic data and concomitant medications obtaining a brief physical examination and urine pregnancy test for females of childbearing potential which had to be negative for the patient to enroll in the study and providing patient education on how to assess pain using the Colored Analog Scale CAS The screening visit could occur on the same day as the procedure visit
Upon meeting the eligibility criteria and completing the screening visit patients were assigned the next available sequential patient number in their age group 5-11 years or 12-17 years Based upon a randomized code patients were randomized to receive either S Caine Peel or placebo for 30 minutes before the scheduled vascular access procedure
The study drug application site could be on either the patients left or right antecubital surface and covered an area of 10 cm2 A thin layer approximately 1 mm or the thickness of a dime of the study drug was applied evenly across the area to be treated for 30 minutes Immediately following removal of the study drug the study drug application site was evaluated for erythema edema blanching or other skin reactions The vascular access procedure was then performed
Upon completion of the vascular access procedure the investigators evaluation of procedural pain intensity and assessment of the adequacy of the anesthesia provided by the study drug were completed Following these assessments patients assessed their procedural pain intensity using the CAS All pain evaluations were completed after the first attempt to gain vascular access If the first attempt was unsuccessful and further attempts were required the procedure was stopped and all pain assessments were performed before further attempts at vascular access were made
During the screening visit the study was fully explained to each patients legal guardian and written informed consent was obtained Whenever possible patients provided assent The screening visit also included evaluating eligibility criteria obtaining a medical history including skin type demographic data and concomitant medications obtaining a brief physical examination and urine pregnancy test for females of childbearing potential which had to be negative for the patient to enroll in the study and providing patient education on how to assess pain using the Colored Analog Scale CAS The screening visit could occur on the same day as the procedure visit
Upon meeting the eligibility criteria and completing the screening visit patients were assigned the next available sequential patient number in their age group 5-11 years or 12-17 years Based upon a randomized code patients were randomized to receive either S Caine Peel or placebo for 30 minutes before the scheduled vascular access procedure
The study drug application site could be on either the patients left or right antecubital surface and covered an area of 10 cm2 A thin layer approximately 1 mm or the thickness of a dime of the study drug was applied evenly across the area to be treated for 30 minutes Immediately following removal of the study drug the study drug application site was evaluated for erythema edema blanching or other skin reactions The vascular access procedure was then performed
Upon completion of the vascular access procedure the investigators evaluation of procedural pain intensity and assessment of the adequacy of the anesthesia provided by the study drug were completed Following these assessments patients assessed their procedural pain intensity using the CAS All pain evaluations were completed after the first attempt to gain vascular access If the first attempt was unsuccessful and further attempts were required the procedure was stopped and all pain assessments were performed before further attempts at vascular access were made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None